1. Field of the Invention
This invention relates the treatment of burns, open sores, incisions and wounds. In particular it relates to topical wound therapeutic formulations containing a hyaluronic acid (hyaluronan) and plasma-fibronectin in combination with elements found in amniotic fluid which simulates the fetal in utero wound healing matrix.
2. Description of the Prior Art
The "greying of America" is well documented. People are living longer and have expectations for a quality life as well as well as a long life.
People afflicted with long term illness run the risk of getting bed sores, pressure sores and a myriad of skin irritations and chronic wounds.
Looking at the treatment figures for pressure ulcers, just a small part of the entire market, one can quickly see that there is a need to develop products that will effectively treat patients with long term illnesses.
As part of a study using AMA data on admissions to acute hospitals to derive the number of patients at risk of pressure ulcers, the statistics and forecasts are as follows:
______________________________________ PATIENTS 1000's 1989 1990 1995 2000 2005 ______________________________________ STAGE 1 539 547 596 656 718 STAGE 2 779 790 861 947 1037 STAGE 3 180 182 199 219 239 STAGE 4 180 182 199 219 239 TOTAL 1677 1701 1853 2040 2233 ______________________________________
Cancer and the use of radiation to treat the disease is on the rise. In 1960, the lifetime risk of developing breast cancer was 1 in 20. In 1991, the risk is 1 in 8. In 1992 180,000 American women will be diagnosed with breast cancer (one every 3 minutes). This drastic increase in breast cancer is enjoined by a myriad of other cancers which are being treated with radiation and the result is a need for an effective topical treatment to reduce the risk and effect of burn.
Wound healing after surgical intervention has been problematic in all recorded history. The benefits of surgery, even in life-threatening situations, are offset by the formation of disfiguring scar tissue.
Adult wound repair is characterized by fibrosis, scarring, and sometimes by contracture. The results of this deforming process affect every form of surgery and can have devastating consequences. In contrast fetal wound healing proceeds without such fibrosis or scar formation, Michael T. Longaker, M.D., Ernie S. Chiu, B.S., N. Scott Adzick, M.D., Michael Stern, D.D.S., Michael R. Harrison, M.D., and Robert Stern, M.D., Studies in Fetal Wound Healing, V. A Prolonged Presence of Hyaluronic Acid Characterizes Fetal Wound Fluid, Ann Surg, April 1991, pp 292-296.
There is great value in the scientific exploration of the fetal environment. As researchers isolate proteins, carbohydrates and other elements, we gain insight into the delicate balance that creates the only perfect new-life support system capable of facilitating rapid new cell growth and differentiation.
With amniotic fluid, the whole is truly greater than the sum of its parts. It is known that hyaluronic acid bonds with fibronectin and together they have a powerful effect on the body's cellular matrix. It is also known that urea, produced by the fetus has an effect on cell migration. Elements such as glucose, protein, sodium, potassium, calcium, magnesium, phosphate and chloride that form the amniotic fluid, work together with an inseparable bond and synergy.
The prior art has isolated key elements of the amniotic fluid and disclosed products for the treatment of wounds, but none have sought the synergy of elements that create the only perfect healing environment.
Several prior art patents disclose therapeutic formulations including hyaluronic acid. Lindblad, "Hyaluronic Acid Preparation used for Treating Inflammations of Skeletal Joints "; U.S. Pat. No. 4,801,619 disclosed the use of hyaluronic acid for intra-articular administration for the treatment of steroid arthropathy and progressive cartilage degeneration caused by proteoglycan degradation. Langerman, "Spare Parts for Use in Ophthalmic Surgical Procedures" U.S. Pat. No. 4,888,016 disclosed the use of hyaluronic acid in ophthalmic surgery as an artificial "spare part" for surgical implantation in the eye during an extracapsular cataract extraction. Alvarez, "Three Step Wound Treatment Method and Dressing Therefor"; U.S. Pat. No. 4,813,924 disclosed the use of hyaluronic acid in the third step of a three step treatment. The invention calls for the hyaluronic acid to be in a hydrocolloid dressing which will provide controlled delivery over a period of 24 to 96 hours to promote thickening of the epidermal cells, thus strengthening the wound. Balazs et al, "Cross-Linked Gels of Hyaluronic Acid and Products Containing Such Gels"; U.S. Pat. Nos. 4,582,865, 4,636,524, and 4,636,865 disclosed the use of cross-linked gels of hyaluronic acid as a drug delivery system.
None of these prior art references claim to use medical grade hyaluronic acid and tissue culture grade plasma-fibronectin in the treatment of burns, open sores, incisions, and wounds and there is no combination with calcium, phosphate, uric acid, urea, sodium, potassium, chloride, and magnesium, which combine to simulate amniotic fluid.
Several prior art patents disclose therapeutic formulations including fibronectin. Gibson et al, "Wound Healing Composition and Method"; U.S. Pat. No. 5,053,388 disclosed the use of a solution containing a protein crosslinking compound such as dimethyl pimelimidate dihydrochloride, followed by fibronectin to improve wound healing particularly wounds of the eye. Reich, "Wound Healing Dressing and Method"; U.S. Pat. 4,973,466 discloses the use of a wound healing dressing comprised of flocculating fibronectin that produce a water-swellable gel useful in promoting healing of corneal, scleral dermal, incisional wounds and lesions obtained in keratorefractive surgeries. Silver et al., "Biodegradable Matrix and Methods for Producing Same," U.S. Pat. No. 4,970,298 discloses a biodegradable matrix which comprises collagen, hyaluronic acid and fibronectin which enhance healing of wounds. Collagen, which is oversecreted by the body in response to an injury or wound, is know to be responsible for scar formation. Georgalas et al., "Skin Treatment Composition and Method for Treating Burned Skin," U.S. Pat. 4,839,019, discloses a composition which counteracts moisture loss and promotes healing of burned or sunburned skin comprised of polyglycerylmethacrylate, glycerine, allantoin, panthenol, amino acid complex, and fibronectin.
None of these references claim to use medical grade hyaluronic acid and tissue culture grade plasma-fibronectin in the treatment of burns, open sores, incisions, and wounds and there is no combination with calcium, phosphate, uric acid, urea, sodium, potassium, chloride, and magnesium, which combine to simulate amniotic fluid.
What is needed is a delivery system for medical grade hyaluronic acid and tissue culture grade plasma-fibronectin that is compatible with needs of the wound environment, and creates a moist healing environment that replicates the amniotic fluid that supports rapid, scar-free healing in utero.